Pechevsky valikardol-natur

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PECHAYEVSKIY VALICARDOL-NATUR

Composition:

Active substances: menthol solution in methyl ether of isovaleric acid, dry extract of hawthorn flowers and leaves, dry extract of hops cones, dry extract of dog nettle;

One tablet contains: menthol solution in methyl ether of isovaleric acid 60 mg, dry extract of hawthorn flowers and leaves (Crataegifoliicumflore) (4–6:1) (extractant – ethanol 75%) 50 mg, dry extract of hops cones (Lupuliflos) (4–6:1) (extractant – methanol 30%) 50 mg, dry extract of dog nettle (Leonuruscardiaca) (4:1) (extractant – ethanol 50%/water 50%) 25 mg;

Excipients: mannitol (E 421), sorbitol (E 420), fructose, povidone 25, sodium cyclamate, magnesium stearate, anhydrous colloidal silicon dioxide.

Pharmaceutical form. Sublingual tablets.

Main physicochemical characteristics: single-layer, round-shaped tablets with convex upper and lower surfaces, light green to brownish-green in color. Green and brown specks may be present on the tablet surface. Under magnification, a relatively homogeneous structure is visible in the cross-section.

Pharmacotherapeutic group.

Combined cardiovascular agents.

ATC code C01EX.

Pharmacological Properties

Pharmacodynamics

A combination drug containing a solution of menthol in methyl isovalerate and extracts of hawthorn, hops, and dog nettle. The solution of menthol in methyl isovalerate exerts a sedative and moderate reflex vasodilating effect (including coronary vasodilation) due to stimulation of nerve receptors. This process is accompanied by induction of the release of endogenous physiologically active substances involved in the regulation of the nervous and cardiovascular systems.

The phytoextracts (hawthorn, dog nettle, and hops) contained in the drug have a sedative effect and exhibit vegetostabilizing and moderate spasmolytic activity.

The drug reduces psycho-emotional tension, increased sensitivity to external stimuli, and associated manifestations of vegetative dysfunction, including sleep disturbances. The effect of the drug develops within 5 minutes after sublingual administration.

Pharmacokinetics

Pharmacokinetic studies of the drug have not been conducted.

Clinical characteristics.

Indications.

• Functional cardialgia;
• neurocirculatory dystonia of the cardiac type;
• neuroses, including those with impaired nighttime sleep;
• hysteria;
• motion sickness (sea and air sickness) – symptomatic therapy;
• headache associated with nitrate intake.

Contraindications.

Hypersensitivity to the components of the drug. Marked arterial hypotension, acute myocardial infarction, bradycardia.

Interaction with other medicinal products and other forms of interactions.

Reduces the intensity of headache caused by nitrates. May potentiate the pharmacological effects of cardiac glycosides, antiarrhythmic and antihypertensive agents. Enhances the effects of sedatives, hypnotics, psychotropic drugs, alcohol, anesthetics, and opioid analgesics.

The simultaneous use of the drug with alkaloid salts is not recommended due to the formation of a precipitate.

Special precautions for use.

If chest pain does not subside after taking the medication, it is essential to consult a physician immediately to rule out acute coronary syndrome.

When using the drug as part of combination therapy for angina attacks, if no effect occurs within the first 5 minutes, nitrates should be administered.

The drug should be used with caution in patients with gastrointestinal disorders in the acute phase and in patients with arterial hypertension.

Patients with diabetes mellitus should consult their physician before using the drug, as one tablet contains 35 mg of fructose.

Mannitol (E 421) contained in the medicinal product may have a mild laxative effect.

The medicinal product contains sorbitol (E 420); therefore, if you have been diagnosed with intolerance to certain sugars, consult your physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy is contraindicated. It is unknown whether the drug passes into breast milk; therefore, if it is necessary to use the drug, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

During treatment with this drug, patients should refrain from driving or operating machinery, as dizziness, drowsiness, and reduced psychomotor reaction speed may occur.

Method of administration and dosage.

Hold the tablets in the oral cavity (under the tongue) until completely dissolved.

The single dose for adults is 1–2 tablets twice daily; the daily dose is 2–4 tablets.

The duration of treatment is determined individually.

Children.

There is no experience with the use of the drug in children.

Overdose.

Symptoms: headache, nausea, dizziness, excitement, cardiac dysfunction, decreased arterial pressure, central nervous system depression, hypersensitivity reactions to the drug components (angioneurotic edema, urticaria, itching, rash). Exacerbation of other adverse reactions.

Treatment: discontinuation of the drug and symptomatic treatment.

Side effects.

Adverse reactions to the drug may occur in some patients, namely:

Cardiovascular system: bradycardia, transient arterial hypotension;

Nervous system: dizziness, somnolence;

Gastrointestinal tract: abdominal discomfort, mild nausea, vomiting, intestinal disturbances;

Eyes: lacrimation;

Immune system: hypersensitivity reactions to drug components (including angioedema, urticaria, itching, rash, hyperemia, skin swelling);

Other: increased fatigue.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature of 8 °C to 15 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister;

10 tablets in a blister; 1 blister per cardboard pack;

10 tablets in a container; 1 container per cardboard pack.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and place of business.

8 Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.